Table 1-1

Consolidation of standards for reporting trials–CONSORT

HeadingSubheadingDescriptorWas it reported?
TitleIdentify the study as a randomised trial
AbstractUse a structured formal
IntroductionState prospectively defined hypothesis, clinical objectives, and planned subgroup or covariate  analyses
 Planned study population, together with inclusion/exclusion criteria
 Planned interventions and their timing
 Primary and secondary outcome measure(s) and the minimum important difference(s) and   indicate how the target sample size was projected
 Rationale and methods for statistical analyses, detailing comparative analyses and whether they   were completed on an intention to treat basis
 Prospectively defined stopping rules (it warranted)
Assignment Describe
 Unit of randomisation (eg, individual, cluster, geographic)
 Method used to generate the allocation schedule
 Method of allocation concealment and timing of assignment
 Method to separate the generator from the executor of assignment
Masking (blinding) Describe mechanism (eg, capsules, tablets); similarity of treatment characteristics
  (eg, appearance, taste); allocation schedule control (location of code during trial and when   broken); and evidence for successful blinding among participants, person doing intervention,   outcome assessors, and data analysts
Participant flow and follow upProvide a trial profile (fig) summarising participant flow, numbers and timing of randomisation  assignment, interventions, and measurements for each randomised group
AnalysisState estimated effect intervention on primary and secondary outcome measures, including a point  estimate and measure of precision (confidence interval)
State results in absolute numbers when feasible (eg, 10/20, not 50%).
Present summary data and appropriate descriptive and inferential statistics in sufficient detail to  permit alternative analyses and replication
Describe prognostic variables by treatment group and any attempt to adjust for them
Describe protocol deviations from the study as planned, together with the reasons
CommentState specific interpretation of study findings, including sources of bias and imprecision (eternal  validity) and discussion of external validity, including appropriate quantitative measures when  possible
State general interpretation of the data in light of the totality of the available evidence